Time to Disrupt SOPs

Boaz Sigelman

I recently bought a new pair of shoes without trying them on. In fact, I’ve not even seen them in real life. I made my purchasing decision based on a video review I watched on an ecommerce site and I got exactly what I expected.

This probably comes as no surprise, as mobile video cameras (smartphones) and video sharing platforms (like YouTube) have been around for years, utilized by many millions in ways similar to what I described above.

But not by pharmaceutical companies. Excluding negligible exceptions, they still maintain some of the most hard-to-learn, easy-to-forget, mandatory content in word documents. In 2017, Standard Operating Procedures (SOPs), Working Instructions (WIs) and other related content are mostly textual documents fit to be printed out on paper and consumed in that manner, just like when I first learned this subject matter, way back in 2002.

Going back to my online acquisition, I could have read (and understood) a document containing thousands of words that specify exactly what these shoes are made of, sole, body, laces and the rest, and what their shape, color, width and length are - I could have easily answered five multiple choice questions on the subject and still have only little idea what to expect when I open the shoebox.  A 30 second clip solved all that.

So why aren’t pharmaceuticals using videos in SOPs? Aren’t lifesaving drugs important at least as new shoes?

The reason, at first glance, seems to be regulation. Health agencies such as the FDA and EMA demand electronically signed word based SOPs to achieve GxP compliance. Way back when the guidelines were written, producing a video involved a lengthy and expensive production, similar to an eLearning course. Viewing it required additional setup too. As companies had (and still have) thousands of living SOPs that are updated constantly, video was considered an unfeasible burden and therefore, eliminated.

Today, similar arguments can be made against introducing Virtual or Augmented Reality into this context - but not videos. Videos are simple to make, and even easier to consume. Every six-year-old with an iPhone can create, share and watch videos - but the six year old’s parents, working in the pharmaceutical industry, need to read and memorize manufacturing, clinical and laboratory related procedures.

Acknowledging that an employee read and understood the content of a document is enough for compliance purposes but Quality departments should strive for more than just compliance training. That can be better achieved by using video.

Visual SOPs can immediately achieve better learning and result in less defective batches, less recalls and less warning letters - the dream of any QA Director and, also, of any FDA executive.

So why aren’t the pharmas using video? the real reason in my mind is conservatism. Obviously, the Pharmaceutical industry is conservative for a good reason - it is accountable for the health of the world population. That is some burden...

However, there is room for innovation even in the most conservative of places and with the emergence of eHealth (combining healthcare and cutting edge technology like never before), the agencies are showing that there are much more aware of the need to innovate.

I indicated that cost used to be a major factor and truth is that it still is and will always be. A shift towards video requires some organizational change management efforts (new processes) that don't come cheap.

Having said that. Luckily, there is a video solution fit for the industry’s current state and requiring minimal changes, easily supported by existing Document Management and Learning Management platforms.

Using text and video in parallel

Companies should create short video clips for SOPs and Instructions documents, linking between text and video via relationships.

As I indicated, this will not require additional procurement as all required hardware and software, both on the servers and for the end users, are mature and in production.

Employees should be trained on both paper and video. At first this will be a duplicate, requiring more effort – but the reward will be immediate with improved effectiveness of the training, resulting in less human errors.

When video is introduced to the Quality process, it won’t be long until more and more uses are discovered, better training is created and the requirement to eliminate the textual redundancy is made backed by with real life data.

So before we turn our labs to Augmented Reality arcades and before we let robots manufacture pharmaceuticals, let’s go one small step forward and use the tools we have available in hand to help humans improve how they make them.

Boaz Sigelman is a program and project director and a senior change leader. He headed both the Document Management System (EDMS/ECM) and Learning Management Systems (LMS) at Teva Pharmaceuticals.